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COL08939 Carboy Brochure April 2019.Indd

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COL08939 Carboy Brochure April 2019.Indd Nalgene carboys for bulk storage of drugs and reagents Superior containers to maximize product security All carboys are not created equal Thermo Scientific™ Nalgene™ containers are made with high-quality resins, and meet the rigorous pharmaceutical high-quality resins that meet pharmaceutical, laboratory, production, laboratory and foodgrade standards. Our and food grade standards. That’s why millions of Nalgene resins are selected to minimize additives and reduce carboys and bottles are at work in bioproduction facilities potential leachables. We do not use plasticizers or fillers, and laboratories around the world. Choose from a and our plastics have low total ash content—a measure wide range of quality carboys and jerricans to fit your of impurities. application requirements—from collecting and mixing reagents, media, and bulk vaccines to storing active Nalgene carboys minimize risk, protecting your pharmaceutical ingredients. valuable products • Leakproof* to help ensure contained materials are not Trust the proven performance of Nalgene containers lost during storage or transport When selecting carboys for critical bioproduction applications, standard laboratory carboys fall far short • Sterile, single-use options to eliminate the need for of what is required for this highly regulated in-house packaging and sterilization industry. We provide the necessary application • Container designs that enable cleaning validations support and documentation, as well as a robust customer notification process. Customization with • Sanitary fitting options for easier cleaning validations fluid transfer options and presterilized carboys and processes are additional benefits you can expect from the • Validation binders and forced extraction studies to Thermo Scientific™ Nalgene™ portfolio. support regulatory compliance Thermo Scientific™ Nalgene™ containers are made with Shatter-resistant plastic containers are less likely to break than glass. The high-quality materials and construction of Nalgene containers enhance this advantage, assuring protection for your valuable products. * Our guarantee for a leakproof seal is subject to our standard product warranty, as set forth in the Thermo Fisher Scientific Terms and Conditions of Sale. Our products are leakproof at ambient temperature and pressure when used with their corresponding closures. However, to ensure safe usage, customers are advised to test our containers and closures under conditions of their planned applications. Our leakproof guarantee We stand behind every Nalgene carboy and Anatomy of a Nalgene carboy jerrican you buy Nalgene carboys and closures are designed, Nalgene carboys and closures are engineered to work manufactured, and supported with the rigorous needs of together with a strong, semi-buttress thread design the pharmaceutical and biologics markets in mind. that prevents stripping. We off er a leakproof guarantee because we manufacture and test both components together as part of our routine quality inspection process (see page 15 for details). If any Nalgene container doesn’t meet our leakproof standards, simply return it to us and we will replace it—guaranteed. The seal ring is molded inside the closure. It fi ts tightly against the beveled inner edge (chamfer) of the bottle neck. For dissimilar materials (HDPE carboy with PP closure), no gasket is required. For PP-to-PP sealing, a gasket is added for extra security of the seal. Threads on bottles and closures have continuous, straight-shouldered semi-buttress threads, not low-quality round threads. The closure is manufactured and tested to work with the carboy and jerrican threading. The closure and bottle system work together to supply a guaranteed leakproof system. Nalgene carboys feature a stable base and bottoms with curved inner corners for easy cleaning—no sharp edges or voids that could cause diffi cult cleaning validations or nonhomogeneous stirring 3 Forced extraction study reports The qualifi cation and validation of production, harvest, Combined with NIST98K, Wiley, and other databases, and containment supplies is an integral part of any these techniques provide the information required to biopharmaceutical application process. Regulatory profi le and identify any signifi cant extractables from each guidelines around the world recommend that the component tested. The evaluation of extractables is based production, storage, and packaging components are on the semi-quantitative estimation of analytes obtained by assessed for extractables or leachables that may interact these techniques. with or impact the product being manufactured. An analysis protocol is available for review upon request To support you, we commissioned studies to identify under a confi dential disclosure agreement (CDA), defi ning compounds that may be extracted from key components the strategy utilized to perform the extraction process. under extreme conditions, and to estimate the quantity of these compounds. These studies are designed to guide you to choose the correct container to show what typical extractable and leachables may be expected when conducting your own studies for submission. 1 2 3 Studies were conducted on two Three extraction solvents were Each extracted solution was diff erent Nalgene carboy systems: used on each unit for the forced subsequently analyzed by: • Nalgene PP carboys and closures extraction process: • Headspace Gas Chromatography/ (TPE gasket and PP white closure) • Water Mass Spectrometry (GC/MS) for volatile and Direct Injection GC/MS • Nalgene sterile HDPE carboys and • Ethanol* for semi-volatile organic compounds closures (PP white closure) • Hexanes* • Liquid Chromatography/Mass • 10% nitric acid** Spectrometry (LC/MS) for non- volatile organic compounds * Direct injection GC/MS and LC/MS analysis. ** ICP/OES analysis only. • Inductively Coupled Plasma (ICP) for metals and elemental extractables using an acid-digested solution 4 In addition to forced extraction studies for the carboy systems, several other studies are available across the Nalgene storage solutions portfolio Forced extraction studies For specifi c compliance needs, you may fi nd the Description Cat. No. following guides helpful: Nalgene PETG Bottles (System, irradiated at • FDA Guidance for Industry: Container Closure Systems 105-0001 19-28 kGy) for Packaging of Human Drugs and Biologics— Nalgene PETG Bottles (System, irradiated at Chemistry, Manufacturing, and Controls Documentation, 105-0010 20-45 kGy) May, 1999 Nalgene PC Biotainers Bottles (System, US Resin) 105-0002 • EMEA Guideline on Plastic Immediate Packaging Nalgene PP Carboys (System) 105-0003 Materials, CPMP/QWP/4359/03 and EMEA Nalgene PETG Biotainers Bottles (System) 105-0004 CVMP/205/04, European Medicines Agency, May, 2005 Nalgene Sterile HDPE Carboys (System) 105-0007 Understand the diff erence between extraction studies and the leachables studies Extractables These are chemical entities that migrate from any product contact material when exposed to an appropriate solvent under exaggerated conditions of time and temperature. The solvents and conditions are meant to be extremely aggressive and designed to represent “worst-case” results. Leachables Leachables consist of chemical compounds that are typically a subset of extractables that can migrate from the contact material into stored solutions under normal process conditions and/or accelerated conditions. Leachable studies are designed to produce results representative to actual application and use of the products. For more information, contact us at rocregsupport@thermofi sher.com 5 High-density polyethylene (HDPE) Ideal for harsh conditions where excellent chemical compatibility is required • Leakproof PP screw0-top design • Wide range including heavy-duty for extra-aggressive conditions, amber for light-sensitive products, and wide- mouth design for easy filling and dispensing of liquids • Round for homogeneous stirring • Rectangular shape (jerrican) for efficient use of storage space • Pre-sterilized, single-use options mean no in-house sterilizing or sterilization validation required Recommended applications Media formulation and mixing, aseptic protocols, • Suitable for conditions from –100°C to +120°C aggressive conditions or chemicals, and production where products may adhere to and leach out of containers. Dimensions Height with Capacity, Closure Length, Width/OD, closure, No. per Description L (gal) size, mm mm (in.) mm (in.) mm (in.) Pk/Cs Cat. No. Single-Use Carboy 20 (5.3) 83B — 284 (11.2) 502 (19.8) 1/6 342289-0050* Single-Use Carboy, Molded-in Handles 33 (8.7) 83B — 381 (15.0) 546 (21.5) 1/1 342289-0075 Amber Carboy 10 (2.6) 83B — 250 (9.8) 383 (15.1) 1/6 2256-7020 Fluorinated Carboy 10 (2.6) 83B — 250 (9.8) 389 (15.3) 1/6 2097-0020 Fluorinated Carboy 20 (5.3) 83B — 282 (11.1) 526 (20.7) 1/4 2097-0050 Rectangular Carboy without Spigot 9 (2.4) 100-415 220 (8.7) 153 (6.0) 360 (14.2) 1/6 2211-0020 Rectangular Carboy without Spigot 20 (5.3) 100-415 320 (12.6) 229 (9.0) 399 (5.71) 1/4 2211-0050 Heavy-Duty Rectangular Carboy 20 (5.3) 70 330 (13.0) 228 (9.0) 406 (16.0) 1/4 2214-0050 Heavy-Duty Wide-Mouth Carboy 20 (5.3) 120 305 (12.0) 203 (8.0) 457 (18.0) 1/4 2241-0050** Jerrican Tethered Angled Closure 6 (1.5) 53B 213 (8.4) 176 (6.9) 335 (13.2) 1/6 2240-0015 Jerrican Tethered Angled Closure 10 (2.6) 53B 246 (9.7) 19 9 ( 7.8) 376 (14.8) 1/6 2240-0025 Jerrican Tethered Angled Closure 20 (5.3) 53B 320 (12.6) 245 (9.6) 4 52 (17.8) 1/4 2240-0050 Jerrican Tethered Top Closure 13 (3.5) 53B 290 (11.4) 18 9 ( 7.4) 378 (14.9) 1/4 2243-0013 Jerrican Tethered Top Closure, 53B, 13 (3.5) 290 (11.4) 18 9 ( 7.4) 378 (14.9) 1/4 2243-9013 38 mm Spigot 38-430 Fluorinated Jerrican 10 (2.6) 53B 246 (9.7) 19 9 ( 7.8) 376 (14.8) 1/6 2242-0025 Fluorinated Jerrican 20 (5.3) 53B 320 (12.6) 245 (9.6) 4 52 (17.8) 1/4 2242-0050 Accessories Handle for 20 L Single-Use Carboy (Stainless Steel) 1/1 2229-0001 53B Replacement Closure and Strap for Jerrican 10/10 712240-1053 38-430 Replacement Closure for Large Nalgene Bottles 12/12 712160-0384 53B Replacement Closure for Large Nalgene Bottles or Carboys 12/12 712160-0530 83B Replacement Closure for Large Nalgene Bottles or Carboys 2/2 712160-0830 * Handle must be purchased separately.
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